Suture management and tensioning devices and methods for soft tissue reconstruction or bone-to-bone fixation

ABSTRACT

An adjustable, stand-alone tensioning system requires no additional fixturing, weights, or bone surface modification, and allows a single practitioner to provide an adjustable and repeatable tension to a soft tissue graft, and to install the final fixation implant. Its design facilitates introduction of the suture component of the graft into the tensioning process by simplifying retention of the suture. An even, regulated and reproducible tension is easily achieved without requiring the practitioner to manually pull on the suture strands to maintain graft tension.

This application claims the benefit under 35 U.S.C. 119(e) of the filingdate of Provisional U.S. Application Ser. No. 60/860,533, entitledSuture Management and Tensioning Device for Soft Tissue Reconstructionor Bone-to-Bone Fixation, filed on Nov. 21, 2006, which application isexpressly and entirely incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to devices, systems and methodsfor material fixation, and, more particularly, to suture management andtensioning devices used during soft tissue reconstruction orbone-to-bone fixation that will assist in the repair of many soft tissueinjuries, such as in the reconstruction of the Anterior CruciateLigament (ACL).

Prior to completing the final steps of fixation during an ACL repair,the reconstructed ligament must be tensioned in order to establish jointstability. Current devices used to establish ligament pretension requirethe practitioner to apply and maintain a manual tensile force of thegraft during tibial fixation. Devices relying on this technique haveproven to be cumbersome, and oftentimes require time consuming steps toprepare the suture component of the tensioning process. These devicesalso require unnecessary physical exertion, and often require anadditional assistant during the final phases of graft fixation. Stillother ligament tensioning devices require external fixturing and/ormodification of the bone surface to support the tensioning process.

Studies have shown that the magnitude of tension affects characteristicssuch as the maximal anterior translation or subluxation of the joint. Inone study, it was found that a higher graft pretension significantlyreduced postoperative anterior-posterior knee laxity. However, optimaltensioning of the reconstructed ligament may be related to graftstiffness, and different ligament reconstruction systems and grafttissue types create different stiffness values. Additionally, theoptimal graft tension for men and women may be different. According to asecond study, too high of an initial tension may increase theanterior-posterior knee laxity in women though the specific effects ofdiffering graft tensions between genders is unknown. Further research inthis area may find an optimal pretension value for each sex.

The tendons of the Gracilis and Semitendinosus muscles are commonlyharvested for use in ACL reconstruction. The tendons are doubled over tocreate a four strand graft complex. During ACL reconstruction thestrands are sutured to form a paired complex of either of two strandssutured together. The strength and stiffness of the graft complextypically surpass that of the native ACL, and both characteristics areoptimized when a relatively even tension is applied to each of the fourtendon strands.

The ConMed™ Linvatec Stress Equalization (SE™) Graft Tensioning Systemis a soft tissue graft tensioning system with the ability to applydifferent tensions to either of two sides of a graft in order toequalize stress in grafts of non-uniform diameter. The system requiresmultiple accessories and additional drill holes to fixate the systemwithin the bone so that tension can be established.

The DePuy Mitek Tie Tensioner is a soft tissue graft tensioning devicethat requires the user to manually apply and maintain a force distal tothe patient. Even tension can be achieved with this device, but requiresthat the suture ends be tied together to form two loops of equal length.Furthermore, limitations in the range of motion of the device'sswiveling suture slide can prohibit true equality in graft strandtension. The Bio-INTRAFIX Surgical Technique manual specifies that theTie Tensioner be used to manually apply a force of approximately 40 lbs.to the sutures while the knee is cycled to eliminate graft creep. Thislevel of exertion often requires an additional assistant to pull the TieTensioner while the knee is cycled. After cycling the knee, the surgeonmust maintain a force of at least 10 lbs. while the Intrafix sheath isinserted and screwed into place. Furthermore, the sheath must usually behammered into place while tension is maintained, often requiring theassistance of an additional technician.

SUMMARY OF THE INVENTION

The inventive device is an adjustable, standalone tensioning system thatrequires no additional fixturing, weights, or bone surface modification,and allows a single operator to provide an adjustable and repeatabletension to a soft tissue graft, and to install the final fixationimplant. Its design facilitates introduction of the suture component ofthe graft into the tensioning process by simplifying retention of thesuture. An even, regulated and reproducible tension is easily achievedwithout requiring the user to manually pull on the suture strands tomaintain graft tension. Furthermore, the benefits of the device's suturemanagement system, coupled with its ability to maintain tension on thegraft, minimizes obstructions surrounding the installation site andeases installation of the final fixation implant. Therefore, mostsurgeons will be able to use the device without requiring additionalassistance during the tensioning and final fixation procedure.

The present invention is a device that is easy to use, requires noadditional accessories, uses only one drill hole, and can be implantedby one practitioner. A primary goal of the inventive system and methodsis to provide a means of applying a repeatable, selectable graft tensionwithout causing additional patient trauma and to minimize the number ofsteps and time required to complete the soft tissue graft fixation. Thedevice requires fewer steps and less time to operate than currentstate-of-the-art devices in use.

Another primary goal of the inventive device is to minimize theprobability that an additional assistant be required to complete thefixation of the soft tissue graft. The device is designed so that a highinitial tension can be used by a single operator to cycle the knee andeliminate graft creep, then released and reset to another value ifdesired for final fixation.

More particularly, in one aspect of the invention, there is provided asuture management device for use during an orthopedic procedure, whichcomprises a body. The device body has structure for accommodating alength of suture and a surface for engaging a portion of a patient'sbody for stabilizing the suture management device relative to aprocedural site within the patient's body. Additionally, the bodycomprises a suture tensioning spring and a suture tensioning control,preferably a rotatable knob, engaged with the suture tensioning spring,for retracting the length of suture to place soft tissue to which thesuture is attached in tension.

The suture management device as described above preferably furthercomprises a force level indicator for assisting an operator in setting adesired tensioning level. A stop is provided for limiting a distancethrough which the suture may be retracted, in order to limit tensionimposed on the suture to a desired amount. A channel disposed in thebody is provided for accommodating a tool for performing steps of theorthopedic procedure.

In one embodiment of the invention, the above mentioned surfacecomprises an outer surface of the body. The body comprises a centerportion for channeling the length of suture between the soft tissue tobe tensioned and the suture tensioning control. The body furthercomprises a first tensioning apparatus connected to the center portionand extending in a first direction, and a second tensioning apparatusconnected to the center portion and extending in a second opposeddirection. The first tensioning apparatus includes the above notedsuture tensioning spring and suture tensioning control, and the secondtensioning apparatus includes a second suture tensioning spring and asecond suture tensioning control. The center body portion preferablycomprises a curved surface and a pair of posts for retaining the suturein the center body portion.

Preferably, each of the first tensioning apparatus and the secondtensioning apparatus further comprise a sliding suture cleat forreceiving an end of a suture length opposed to the end connected to thesoft tissue to be tensioned, wherein the sliding suture cleat slidesresponsive to actuation of the suture tensioning control.

In another embodiment of the invention, the surface is disposed on aforce displacement arm which extends distally of the body. A forcedisplacement tube is connected to a proximal end of the forcedisplacement arm. A proximal end of the force displacement tube engagesthe suture tensioning spring. The device further comprises a rotatablesuture spool for accommodating a portion of the length of suture as thesuture is retracted by the suture tensioning control.

In another aspect of the invention, there is disclosed a method oftensioning a portion of soft tissue during an orthopedic procedure at anoperative site in a patient's body. The disclosed method comprises stepsof positioning a body of a suture management device at a desiredlocation in proximity to the operative site, and attaching a first endof a length of suture to a portion of soft tissue to be tensioned,wherein the second end of said length of suture is attached to a sutureretaining member disposed within the suture management device body. Asuture tensioning control is actuated to retract the length of sutureinto the body, thereby tensioning the portion of soft tissue, and thetension applied to the portion of soft tissue is limited to a desiredlevel.

In one variant of the method, the tension limiting step is performed bypre-setting a tension level using a tension adjusting control on thedevice. In another method variant, the tension limiting step isperformed by actuating the suture tensioning control until a force gaugeindicates that the desired tension level has been applied.

The method disclosed above comprises an additional step of inserting atool through a channel in the body to deploy an implant. Then, thedevice is removed from the patient's body.

The invention, together with additional features and advantages thereof,may best be understood by reference to the following description takenin conjunction with the accompanying illustrative drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an isometric exploded view of an embodiment of a deviceconstructed in accordance with the principles of the present invention;

FIG. 1B is a detailed view of the portion of FIG. 1A delineated bycircle 1B;

FIG. 2 is an isometric view of the assembled device of FIG. 1A;

FIG. 3A is a view from one side of the device of FIGS. 1 and 2;

FIG. 3B is a view of the device of FIG. 3A from an orientation 90degrees rotated from that of FIG. 3A;

FIG. 3C is a view from one end of the device of FIG. 3A;

FIG. 3D is a view from the opposed end of the device of FIG. 3A;

FIG. 4A is an isometric view illustrating a clinical application of thedevice of FIGS. 1-3;

FIG. 4B is a detailed view of the portion of FIG. 4A delineated by thecircle B, taken from the side;

FIG. 5 is a perspective view of a modified embodiment of the suturetensioning device of the present invention;

FIG. 6 is an exploded view of the suture tensioning device of FIG. 5;

FIG. 7 is a detailed view of the portion of FIG. 6 which is delineatedby circle 7; and

FIG. 8 is a view illustrating a clinical application of the device ofFIG. 5.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now more particularly to the drawings, there is shown in FIGS.1-3 a suture tensioning device 10 comprised of a body 12. The device 10comprises a force displacement arm 14, which functions to fix the device10 against the wall of a tibial tunnel 15 (FIG. 4A), as will bedescribed hereinbelow. The force displacement arm 14 is shaped toflexibly accommodate different topographies with acceptable clearancefor both the final fixation implant and any installation tools. Withslight modification of the design, the force displacement arm 14 may bemade removable and replaceable so that the tensioning device 10 can beeither a single use device or reusable.

Proximal to the force displacement arm 14 is a suture guide knob 16.Fasteners 18 (FIG. 1A) secure the force displacement arm 14 to a forcedisplacement tube 20 within the suture guide knob 16. The device 10further comprises a plurality of suture drawers 22. Pins 24 are adaptedfor insertion through pin apertures 26 in the suture drawers 22. Arotatable suture spool 28 is provided, on which are disposed a pluralityof thumb levers 30.

Fasteners 32 extend through a flange 34 on the rotatable suture spool28, for attaching the flange 34 to a ratchet gear 36, through apertures38. A spring collar stop 40 and a tensioner spring 42 are disposedwithin the rotatable suture spool 28, as shown in FIG. 1A. Slidableabout a proximal end of the tensioner spring 42 is a spring collar slide44. A pawl 46 and a ratchet torsion spring 48 are provided, wherein theratchet torsion spring 48 is disposed about an adjustment slide rod 50.An adjustment lock 52 and a sliding stop 54 are also provided, as shown.At a proximal end of the device 10, there is provided a tensioning knob56.

Within the tensioning knob 56 are disposed, in cooperating relationship,an adjustment cover 58, a washer retainer 60, and a gauged cover plate62. Fasteners 64 assist in securing the adjustment cover 58, washerretainer 60, and gauged cover plate 62 within the tensioning knob 56. Atension adjust button 66 extends proximally from the adjustment cover,and is connected to an adjustment spring 68 and a spring support washer70, which, in turn, are operatively disposed on a proximal end of theadjustment slide rod 50.

Now with reference to FIGS. 4A and 4B, a method for using the device 10will be described. In this particular example, the suture tensioningdevice 10 is used in the performance of an ACL repair, of the typesdisclosed in U.S. Patent Application Publication No. 2006/0155287,entitled Devices, Systems, and Methods for Material Fixation, in U.S.patent application Ser. No. 11/725,981, entitled Devices, Systems, andMethods for Material Fixation, filed on Mar. 20, 2007, and in U.S.patent application Ser. No. 11/923,526, entitled Methods & Systems forMaterial Fixation, filed on Oct. 24, 2007. All of these priorapplications are commonly assigned with the present application, and areherein expressly incorporated by reference, in their entirety. Thisparticular procedure is exemplary only, as the device 10 and methods ofthe present invention may be used in a variety of procedures duringwhich it is necessary or desirable to tension portions of the tissue.

Illustrated are the femur 72 and tibia 74 of a patient. As graft tendons76 are pulled proximally and become tensioned, displacement isconstrained by the design to occur at the force displacement arm 14,whose load is transferred to the force displacement tube 20, springcollar stop 40, and tensioner spring 42. The displacement of thesecomponents is adjustably limited by the sliding stop 54. This componentcontrols the maximum displacement of the tensioner spring by preventingfurther displacement once it is in contact with the spring collar stop40. The tensioner spring 42 is housed within the spring collar slide 44and is so constrained. The tensile force imposed on the tendons 76 canbe estimated by multiplying the tensioner spring constant by thedisplacement distance traveled by the tensioner spring 42.

Known values of force or a qualitative scale can be marked on theadjustment cover 58 or the force displacement tube 20. The position ofthe tension adjust button 66 indicates the tension setting and relatesthe circumferential position of the sliding stop 54 to a displacementtangential along the spring collar slide 44. The tensioning device isadjusted by depressing the tension adjust button 66 and sliding it tothe desired tension force marked on the adjustment cover 58. The tensionadjust button 66, adjustment spring 68, spring support washer 70, andadjustment slide rod 50 slide along an aligned track 76 a (FIG. 2)formed by the adjustment cover 58, washer retainer 60, and gauged coverplate 62. Depressing the tension adjust button 66 compresses theadjustment spring 68, lowers the adjustment slide rod 50, and thusdisengages the adjustment lock 52 from a mated hole on the perimeter ofthe gauged cover plate 62 corresponding to a specific tension setting.Consequently, the pawl 46 disengages from the ratchet gear 36. As theadjustment slide rod 50 moves circumferentially around the aligned trackformed by the adjustment cover 58, the washer retainer 60, and thegauged cover plate 62, it rotates the sliding stop 54 around theperimeter of the spring collar slide 44. A spiral shaped cut translatescircumferential movement of the sliding stop 54 into a tangential motionalong the length of the spring collar slide 44, thereby adjustablylimiting the maximum possible displacement for the force displacementarm 14, force displacement tube 20, spring collar stop 40, and thus thetensioner spring 42.

Once the desired tension is set, the tension adjust button 66 isreleased, allowing the adjustment spring 68 to return the adjustmentslide rod 50 and to re-engage the adjustment lock 52 into a mated holeof the gauged cover plate 62, which corresponds to the desired tensionsetting. Simultaneously, the pawl 46 re-engages with the ratchet gear 36assisted by the angle-chamfered teeth of the lower half of the ratchetgear 36.

Once the force displacement arm 14 is properly positioned, after thedesired tension is set, suture 77 can be loaded into the suture drawers22. Optionally, the device may be packaged with the suture drawers in astate ready for loading, and in this configuration, any potentialdisplacement of the force displacement arm 14 is prohibited by theinterference created between lower portions of the suture drawers 22 andthe suture guide knob 16. Two or more suture drawers 22 contain a sutureslot feature which can accommodate multiple strands of a plurality ofsuture sizes. Moreover, the suture guide knob 16 also contains two ormore suture slot features 78 (FIG. 4B) which provide channels for thesuture strands to be guided within and removed from hindrance. Thumblevers 30 are attached to the rotatable suture spool 28 by pins 24.Slots in the thumb levers 30 allow movement of the pin 24 press fitthrough the suture drawer 22. When the thumb lever 30 is depressedinwardly toward the rotatable suture spool 28, the suture drawers 22retract into a cavity within the rotatable suture spool 28. The width ofthe suture drawers 22 steps down at the location of the suture slots 78to accommodate the width of the suture as it retracts into the cavity.Once the suture drawers 22 are retracted, the interference between thecavity walls of the rotatable suture spool 28, the suture strands, andthe suture drawers constrains the suture strands 77 from moving.

When the suture strands 77 of approximately equal length have beenpassed through the suture guide knob 16, after the desired tension levelhas been set, and loaded into the suture drawers 22, the device is readyto tension the suture strands and soft tissue graft, to which the suturestrands are connected. The operator simply grasps the suture guide knob16 with one hand while rotating the tensioning knob 56 in a clockwisemotion with the other hand. During the tensioning process, the device isheld parallel to the graft tunnel. The tensioning knob 56 is rotateduntil it stops. At this point, the desired tension has been reached andthe sliding stop 54 has come into contact with the spring collar stop40, thereby prohibiting further displacement of the tensioner spring 42.Tension is achieved as the suture strands 77, whose ends are constrainedwithin the suture drawers 22, wrap and accumulate around the rotatablesuture spool 28. The load propagates along the suture strands, equallytensioning each strand of the soft tissue graft 76.

The tensioning knob 56 rotates the ratchet gear 36 and the rotatablesuture spool 28. The inner components of the device are prevented fromrotating as they are fixed in relation to the suture guide knob 16. Akeyway internal to the spring collar slide 44 and the spring collar stop40 prohibits rotation of the spring collar slide 44 and its attachedcomponents. The pawl 46 is therefore fixed in place relative to thesuture guide knob 16. As the ratchet gear 36 rotates clockwise aroundthe inner components, the pawl 46 alternately moves in a clickingfashion along and opposite to the tangential vector of ratchet gearrotation. The ratchet torsion spring 48 returns the pawl 46 to itsoriginal position between the teeth of the ratchet gear 36. Motion ofthe tensioning knob 56 is restricted to the clockwise direction by afeature on the side of the pawl 46 that interferes with one edge of thesliding stop 54. If motion is attempted in the counter-clockwisedirection, the pawl 46 is obstructed from moving by the sliding stop 54and the ratchet gear 36 is prevented from rotating. The ratchetingmechanism of this device is not limited to the description providedherein, but may also constitute similarly functional configurationsutilizing a variety or a plurality of pawls, gears, teeth or grooves. itis also within the scope of the present invention to utilize a one-way(Sprag freewheel type) rotational bearing in place of the abovedescribed ratcheting mechanism.

If used during the course of a ligament reconstruction procedure, suchas that described in co-pending U.S. application Ser. No. 11/725,981,already expressly incorporated by reference herein, the soft tissuegraft is first located in a tunnel drilled through the tibia, and afemoral anchor is deployed to secure a distal end of the graft in asocket drilled into the femur. Then, the proximal end of the soft tissuegraft is extended proximally through the tibial tunnel and throughreceiving portions of a tibial anchor. Before the tibial anchor isdeployed, the graft is tensioned by pulling it taut, using the device10. After tensioning of the soft tissue graft has been completed, thedevice can be held with one hand while the joint (knee) is cycled toeliminate graft creep. Afterwards, the tension can be readjusted to alower value for final fixation by holding the suture guide knob 16, andwhile disengaging the ratchet mechanism by pressing the tension adjustbutton 66, rotating the tensioning knob 56 counter-clockwise to unwindsome or all suture from the suture spool 28. The new tension can beassessed by looking at where gauged markings on the force displacementtube 20 align with the edge of the suture guide knob 16 or by releasingall tension and repeating the tensioning procedures with the newlydesired value. Once the desired final fixation tension is reached, theimplant is positioned and an implant installation tool 79 is insertedand operated through the center of the tensioning device, as illustratedin FIGS. 4A and 4B. The device is removed from patient contact by eithercutting the suture strands, thus separating the device 10 from the softtissue grafts, or by opening the suture drawers 22 using the thumblevers 30.

A second, modified embodiment of the device of the present invention isillustrated in FIGS. 5-8. In this embodiment, like elements to thoseillustrated in FIGS. 1-4 are delineated by like reference numerals. Theembodiment of FIG. 5 differs from the FIG. 1 embodiment in that thetendon bundles 76 are tensioned laterally to the tibial tunnel 15 (FIG.8) rather than axially. Instead of pushing off of a cortical bonesurface, the device 10 of FIG. 5 rests on the surrounding bone and/ortissue during the tensioning procedure. The device 10 comprises twotensioning assemblies 80, 82 that are symmetric about the center of thetensioner body 12. A center portion 84 of the tensioner body 12 isfilleted with a large radius to provide a smooth transition for thetensile force to translate around the bend of the suture strands to thetendon bundles within the tibial tunnel. The C-shaped center portion 84of the tensioner body 12 is left open, allowing the suture strands 77(FIG. 8) to be passed over the filleted edges of the center portion ofthe tensioner body 12 rather than being threaded through an otherwiseclosed portion. The open center portion 84 also facilitates implantinsertion and installation. The tibial tunnel 15 (FIG. 8) is angled withrespect to the surface of the knee (tibia 74), so the inclusion of twoposts 86 at the edges of the C-shaped center portion 84 of the tensionerbody 12 prevents the sutures 77 from sliding off of the edge of thetensioner body during the tensioning procedure.

The patient contact side of the tensioner body 12 has two sliding suturecleats 88 (FIGS. 6 and 7) located at each end of the device, that fixatethe suture strands of the soft tissue graft for tensioning. Eachtensioning knob 56 is fixed to a force translation screw 90. When theknob is rotated, a threaded force translation nut 92 moves linearlyalong the length of the tensioner body 12. The tensioning nut 92 isprevented from rotating relative to the tensioner body 12 by theextruded portion of the nut that slides within a channel on the topsurface of the tensioner body 12.

The tensioning knob 56 and force translation screw 90 are constrainedwithin the cylindrical cavity of the tensioner body by the outsidediameter of the tensioning knob shaft, which lies partly inside theslightly larger inner diameter of the tensioner body, allowing forrotation of the tensioning knob 56. The end of the force translationscrew 90 opposite to the tensioning knob 56 has a notch machined into itso that it can be installed through a keyhole snap within the tensionerbody 12. The keyhole snap retains the opposite end of the forcetranslation screw and allows only rotational movement of the screw.

As the tensioning knob 56 is rotated in the appropriate direction, theforce translation nut 92 moves away from the center of the tensionerbody and begins to compress the tensioning spring 42, which is press fitover the force translation nut 92 and sliding suture cleat 88,maintaining the motion of the force translation nut and the slidingsuture cleat relative to one another. Each end of the tensioningassembly is designed to remove any slack from the tendon bundles andsuture strands by the allowance for a displacement distance beyond thecombined length of the assembly of the tensioning spring 42, forcetranslation nut 92, and sliding suture cleat 88. Rotating the tensioningknob 56 will remove any slack in the tendon bundles within thisallowance prior to establishing tension.

The tensioning spring 42 directs the compressive force created by thelinear displacement of the translation nut to the sliding suture cleat88 which is constrained from movement by the cleated suture strandsleading into the tibial tunnel. Each force translation screw 90 andforce translation nut 92 may be threaded oppositely to one another,allowing the force translation nuts 92 to compress the tensioningsprings 42 while rotating the tensioning knobs 56 in the same direction,instead of in opposing directions. An indicator pin or other marking onthe force translation nut 92 moves either underneath or relative to aslot on the sliding suture cleat/force gauge 88 which may betranslucent, for purposes of reading the force indicator mark of theforce translation nut 92 if the post and slot configuration is not used.

The sliding suture cleat/force gauge 88 has linear gradient markingswhich relate displacement of the tensioning spring 42 to force in eitherlbf or N. A typical tensioning range for each tendon bundle may be from0 to 30 lbf (0 to 133.45 N). However, the tension on either side of thedevice may be set to any value within this range by rotating thetensioning knob until the desired tension is reached. The design of thedevice allows tension to be set and maintained without requiring thephysician to physically hold the tensioning knobs. Therefore, the devicecan be used by a single physician without additional assistance.

The device is designed so that once tension is established, thephysician can have both hands free to complete the installation of thefinal fixation implant. In the example cited above, involving the repairof an ACL as described in the co-pending '981 application, the finalfixation implant is the tibial anchor, the femoral anchor having alreadybeen installed prior to tensioning. Similar to the ConMed Linvatec SE™(Stress Equalization) Graft Tensioning System, the disclosed devicepermits the physician to independently tension each tissue graft bundleto normalize stress between bundles of differing cross-sectional area,but with fewer steps, greater ease, and less time. Moreover, the designof the tensioning device assists implant installation by separating andspreading the tendon bundles to the edges of the tibial tunnel, thusfacilitating the process of inserting the tibial implant between thetendons. Once the implant is installed, the device is removed frompatient contact by either cutting or unwinding the suture strands fromthe suture cleats.

Accordingly, although an exemplary embodiment of the invention has beenshown and described, it is to be understood that all the terms usedherein are descriptive rather than limiting, and that many changes,modifications, and substitutions may be made by one having ordinaryskill in the art without Departing from the spirit and scope of theinvention.

1-14. (canceled)
 15. A method of tensioning a portion of soft tissueduring an orthopedic procedure at an operative site in a patient's body,comprising: positioning a body of a suture management device at adesired location in proximity to the operative site; attaching a firstend of a length of suture to a portion of soft tissue to be tensioned,wherein the second end of said length of suture is attached to a sutureretaining member disposed within said suture management device body;actuating a suture tensioning control to retract the length of sutureinto the device body, thereby tensioning the portion of soft tissue; andlimiting the tension applied to the portion of soft tissue to a desiredlevel.
 16. The method as recited in claim 15, wherein the tensionlimiting step is performed by pre-setting a tension level using atension adjusting control on said device.
 17. The method as recited inclaim 15, wherein the tension limiting step is performed by actuatingthe suture tensioning control until a force gauge indicates that thedesired tension level has been applied.
 18. The method as recited inclaim 15, and further comprising a step of inserting a tool through achannel in said device body to deploy an implant.
 19. The method asrecited in claim 18, and further comprising a step of removing thedevice from the patient's body.
 20. A method of tensioning a portion ofsoft tissue during an orthopedic procedure at an operative site in apatient's body, comprising: positioning a body of a suture managementdevice at a desired location in proximity to the operative site;attaching a first end of a length of suture to a portion of soft tissueto be tensioned, wherein a second end of said length of suture isattached to a suture retaining member disposed on or about said suturemanagement device body; retracting the length of suture into the devicebody, thereby tensioning the portion of soft tissue; and limiting thetension applied to the portion of soft tissue to a desired level. 21.The method as recited in claim 20, wherein the retracting isaccomplished through manual actuation.
 22. The method as recited inclaim 20, wherein the suture retaining member is a cleat.
 23. The methodas recited in claim 20, wherein the suture retaining member is a slot.24. The method as recited in claim 20, wherein the suture retainingmember is a slot of a cleat.
 25. The method as recited in claim 20,wherein the suture management device is a soft tissue tensioning systemcomprising: a manual suture tensioning device having a generallyT-shape; said device comprising a bar and a finger guard which isorthogonal to the bar; said bar having opposed lateral ends; a lateralsuture cleat disposed on each lateral end of the bar; and a primarysuture cleat extending about a top and a bottom of each of said opposedlateral ends of said bar.
 26. The method as recited in claim 20, andfurther comprising a step of inserting a tool through a channel in saiddevice body.
 27. The method as recited in claim 26, wherein the devicebody is cannulated.
 28. The method as recited in claim 26, wherein thetool deploys an implant.
 29. The method as recited in claim 26, andfurther comprising a step of removing the device from the patient'sbody.
 30. The method as recited in claim 20, wherein the step ofretracting is accomplished by actuating a suture tensioning control. 31.The method as recited in claim 30, wherein the tension limiting step isperformed by pre-setting a tension level using a tension adjustingcontrol on said device.
 32. The method as recited in claim 30, whereinthe tension limiting step is performed by actuating the suturetensioning control until a force gauge indicates that the desiredtension level has been applied.
 33. The method as recited in claim 30,wherein the step of actuating a suture tensioning control isaccomplished manually.
 34. The method as recited in claim 30, whereinthe suture tensioning control is manual.